Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System

Exclusion Criteria

• •Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device
• •Aortic angulations (radius) less than 15mm at intended proximal landing zone.
• •Ascending aortas that would require the arch graft to be deployed less than 15mm distal to the coronaries
• •Pre-procedure occlusion or planned coverage of both subclavian arteries
• •Anatomic variants which would compromise circulation to both vertebral arteries after placement of the stent-graft
• •Prior endovascular repair in the ascending/descending thoracic aorta or aortic arch. The device may not be placed within any prior endovascular graft
• •Concomitant aneurysm/disease of the abdominal aorta requiring repair
• •Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure
• •Prior mechanical aortic valve replacement except for hybrid valves with biological leaflets.
• •Major surgical or medical procedure within 45 days prior to the planned procedure or is scheduled for a major surgical or medical procedure within 60 days post implantation. Except for any planned procedures for the prospective stent-graft placement, e.g., left subclavian artery bypass or transposition
• •Untreatable allergy or sensitivity to contrast media or device components
• •Blood coagulation disorder or bleeding diathesis in which the treatment cannot be suspended for one week pre and post repair
• •Acute Coronary Syndrome (ACS) including unstable angina
• •Severe Congestive Heart Failure (New York Heart Association functional class IV)
• •Stroke within 12 months of the planned treatment date
• •Myocardial infarction within 3 months of the planned treatment date.
• •Chronic atrial fibrillation or other hypercoagulable condition that requires treatment with anticoagulants or presence of left atrial appendage thrombus
• •Severe pulmonary disease (documented FEVI \<30% or as assessed by the study physician) at screening
• •Acute renal failure (defined as serum creatinine \> 2.5mg/dL Note: Patients that have chronic renal failure and are managed medically or through hemodialysis, and can tolerate the follow-up imaging schedule can be included.
• •Significant carotid bifurcation disease (\>70% diameter reduction by duplex ultrasound or angiography)
• •Hemodynamic instability
• •Active systemic infection at the time of treatment
• •Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements
• •Connective tissue disorders, mycotic aneurysms, or infected aorta
• •Less than two-year life expectancy
• •Current or planned participation in an investigational drug or device study that has not completed primary endpoint evaluation
• •Currently pregnant or planning to become pregnant during the course of the study
• •Medical, social, or psychological issues that the Investigator believes may interfere with treatment or follow-up